Linezolid

Orange BookUNIISPLATC J01XX08

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeJ01XX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
6787741901
100 TABLET, FILM COATED in 1 BOTTLE (67877-419-01)
ndc11
6787741905
500 TABLET, FILM COATED in 1 BOTTLE (67877-419-05)
ndc11
6787741910
1000 TABLET, FILM COATED in 1 BOTTLE (67877-419-10)
ndc11
6787741920
20 TABLET, FILM COATED in 1 BOTTLE (67877-419-20)
ndc11
6787741933
1 BLISTER PACK in 1 CARTON (67877-419-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6787741938
10 BLISTER PACK in 1 CARTON (67877-419-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6787741984
3 BLISTER PACK in 1 CARTON (67877-419-84) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6787741985
2 BLISTER PACK in 1 CARTON (67877-419-85) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

ISQ9I6J12J

LINEZOLID

RxCUI 190376

Orange Book

A205517

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "ISQ9I6J12J",
    "rxcui": "190376",
    "inchikey": "TYZROVQLWOKYKF-ZDUSSCGKSA-N",
    "display_name": "LINEZOLID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "374af2a7-d994-40bd-a86a-cd9038d0b72c": {
      "match": "brand_token",
      "title": "LINEZOLID TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]",
      "spl_version": "16",
      "published_date": "2026-05-25"
    }
  },
  "productid": "67877-419_1dd1fb9c-98f4-4e25-8246-fb8462ff381c",
  "productndc": "67877-419",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205517",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Dec 21, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LINEZOLID",
  "proprietary_name": "Linezolid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205517",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Linezolid",
  "start_marketing_date": "20151221",
  "active_numerator_strength": "600"
}

Related drugs

Other records sharing ATC code J01XX08.

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